colorectal cancer patients refractory to conventional treatments
Conditions
Interventions
Anti-IL6 receptor antibody [Actemra (tocilizumab), Chugai Pharmaceutical Co
0.5mg/kg (n=6), 2mg/kg (n=6), or 8mg/kg (n=6)] is intravenously administrated. After three days, a maximum of 4 peptides (3 mg/each peptide), which are selected based on the results of HLA typing and
s adjuvant (Montanide ISA51, Seppic)once a week for consecutive 6 weeks. During the treatment, safety is evaluated.The dose of anti-IL6 receptor antibody is escalated, if the safty is confirmed in 6
Sponsors
Kurume University Cancer Vaccine Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1)Patients must be pathologically diagnosed as colorectal cancer, and refractory to conventional treatments. Target lesions for response evaluation are not essential. The term for wash out of previous treatments should be basically more than 4 weeks, and patients must show no clinical effects or adverse events of previous treatments. 2) Patients must show an elevation of plasma IL-6 more than 3 pg/ml before treatment. 3) Patients must be an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4) Patients must be a positive status for HLA-A2, -A3, -A11, -A24, -A26, -A31, or -A33. 6) Patients must possess positive IgG responses to at least two of the different vaccine candidate peptides in pre-treatment plasma. 4) Patients must have a life expectancy of at least 12 weeks. 6) Patients must satisfy the followings: WBC is between 3,000/mm3 and 9,000/mm3. Lymphocyte is more than 1,000/mm3 Hb is more than 8.0g/dl Platelet is more than 120,000/mm3 Serum Creatinine is less than 1.5 times upper limit of normal. Total Bilirubin, AST, and ALT are less than 2 times upper limit of normal. 8) Patients must be over 20 years old. 9) Written informed consent must be obtained from patients.
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1) Patients with severe underlying diseases (active and severe infectious diseases, activa tuberculosis, circulatory diseases, respiratory diseases, renal diseases, immunodeficiency, disturbance of coagulation, etc). 2) Patients with active interstitial pneumonia or its past history. 3) Patients with active double cancer [synchronic double cancer or asynchronous double cancer with no more than 5-year disease-free period, excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured by local treatment]. 4) Patients with the past history of severe allergic reactions. 5) Patients with Castleman's disease, rheumatoid arthritis, or juvenile idiopathic arthritis or with the past history of them. 6) Patients with the past history of previous tretamnet with anti-IL-6 receptor antibody. 7) Patients with the past history of previous tretament with personalized peptide vaccine developed by Kurume University. 8) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of effective contraception during and for at least 70 days after study participation. 9) Patients with other inappropriate conditions for enrollment judged by the clinicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (adverse events) of personalized peptide vaccine in combination with anti-IL6 receptor antibody. | — |
Secondary
| Measure | Time frame |
|---|---|
| Specific immunological responses after peptide vaccine (anti-peptide IgG titers in plasma and peptide-specific CTL responses in PBMC) . | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Outcome results
None listed